FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE ILS STAPLER
MDR report key: 3980446
·
Received August 5, 2014
Report
- Report Number
- 3005075853-2014-05466
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- July 18, 2014
- Report Date
- July 18, 2014
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K983536
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE MALFORMED STAPLES WERE FOUND AFTER FIRING. THE CRUNCH WAS CLEARLY HEARD DURING THE FIRING. CHANGED TO HAND SEWING TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT. AS THE PATIENT HAD HEPATITIS, SAMPLE HAD BEEN DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456673 | PROXIMATE ILS STAPLER | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | NA | L4E97L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |